Department of Oncology, Division of Medical Oncology, Schulich School of Medicine & Dentistry, Western University and London Health Sciences Centre, London, ON N6A 5W9, Canada.
Cancer Research Laboratory Program, Lawson Health Research Institute, London, ON N6C 2R5, Canada.
Curr Oncol. 2023 Aug 4;30(8):7384-7397. doi: 10.3390/curroncol30080535.
Neither paclitaxel plus trastuzumab (P-H) nor docetaxel-cyclophosphamide plus trastuzumab (TC-H) have been prospectively compared in HER2-positive early-stage breast cancer (EBC). A randomized trial was performed to assess the feasibility of a larger study.
Lower-risk HER2-positive EBC patients were randomized to either P-H or TC-H treatment arms. The co-primary feasibility outcomes were: ≥75% patient acceptability rate, active trial participation of ≥50% of medical oncologists, ≥75% and ≥90% treatment completion, and receipt rate of planned cycles of chemotherapy, respectively.
Febrile neutropenia (FN) rate, treatment-related hospitalizations, health-related quality of life (HR-QoL) questionnaires. Analyses were performed by per protocol and intention-to-treat.
Between May 2019 and March 2021, 49 of 52 patients agreed to study participation (94% acceptability rate). Fifteen (65%) of 23 medical oncologists approached patients. Rates of FN were higher (8.3% vs. 0%) in the TC-H vs. P-H arm. Median (IQR) changes in scores from baseline in FACT-Taxane Trial Outcome Index at 24 weeks were -4 (-10, -1) vs. -6.5 (-15, -2) for TC-H and P-H arms, respectively.
A randomized trial comparing P-H and TC-H was feasible. Expansion to a larger trial would be feasible to explore patient-reported outcomes of these adjuvant HER2 chemotherapy regimens.
紫杉醇联合曲妥珠单抗（P-H）和多西他赛-环磷酰胺联合曲妥珠单抗（TC-H）均未前瞻性比较过用于 HER2 阳性早期乳腺癌（EBC）。进行了一项随机试验以评估更大规模研究的可行性。
低危 HER2 阳性 EBC 患者被随机分配至 P-H 或 TC-H 治疗组。主要可行性结局分别为：≥75%的患者接受率、≥50%的肿瘤内科医生积极参与试验、≥75%和≥90%的治疗完成率，以及接受计划化疗周期的比例。
发热性中性粒细胞减少症（FN）率、与治疗相关的住院治疗、健康相关生活质量（HR-QoL）问卷。按方案和意向治疗进行分析。
在 2019 年 5 月至 2021 年 3 月期间，52 例患者中有 49 例同意参与研究（接受率 94%）。23 名肿瘤内科医生中有 15 名（65%）接触了患者。FN 率在 TC-H 与 P-H 组中较高（8.3% vs. 0%）。在 24 周时，FACT-Taxane 试验结局指数的基线评分中位数（IQR）变化分别为 TC-H 组为-4（-10，-1）和 P-H 组为-6.5（-15，-2）。
比较 P-H 和 TC-H 的随机试验是可行的。扩大到更大规模的试验将能够探索这些辅助 HER2 化疗方案的患者报告结局。
